J Immigrant Minority Health DOI 10.1007/s10903-015-0198-9
ORIGINAL PAPER
A Review of Barriers to Minorities’ Participation in Cancer Clinical Trials: Implications for Future Cancer Research Ali Salman1 • Claire Nguyen2 • Yi-Hui Lee3 • Tawna Cooksey-James4
Ó Springer Science+Business Media New York 2015
Abstract To enhance nurses’ awareness and competencies in practice and research by reporting the common barriers to participation of minorities in cancer clinical trials and discussing facilitators and useful strategies for recruitment. Several databases were searched for articles published in peer reviewed journals. Some of the barriers to minorities’ participation in clinical trials were identified within the cultural social-context of cancer patients. The involvement of community networking was suggested as the most effective strategy for the recruitment of minorities in cancer clinical trials. Using culturally sensitive approaches to enhance ethnic minorities’ participation is important for advancing cancer care and eliminating health disparities. Awareness of barriers and potential facilitators to the enrollment of ethnic minority cancer patients may contribute to enhancing nurses’ competencies of recruiting ethnic minorities in nursing research, playing efficient roles in cancer clinical trials team, and providing culturally competent quality care. Keywords Clinical trials Cancer Ethnic minority Barriers Recruitment
& Yi-Hui Lee [email protected] 1
Faculty of Health Studies, Brandon University, Brandon, MB R7A 6A9, Canada
2
Inova Mount Vernon Hospital, Alexandria, VA 22306, USA
3
College of Nursing and Health, Wright State UniversityMiami Valley, 3640 Colonel Glenn Hwy., Dayton, OH 45435-0001, USA
4
School of Nursing, Ohio University, Athens, OH 45701, USA
Introduction Cancer is a major health concern and the second leading cause of death in the United States, second to heart disease [5]. In 2012, a total of 577,190 cancer deaths were recorded in the United States, and about 580,350 Americans were expected to die of cancer in 2013 [3]. It has been well documented that cancer incidence and death rates vary considerably among different racial and ethnic groups [3, 26, 38]. Many racial and ethnic groups in the United States and around the world are affected disproportionately by certain types of cancers [26]. As a result, it has become a national and global goal to reduce health disparities and promote equality among all people [10]. The importance of culturally competent care has been stressed in nursing research and practice. It has been suggested that including cultural competence in research has a greater potential to inform nursing practice and help to shape health policy related to racial and ethnic minority populations [33]. Nurses, especially oncology nurses, should be aware of the barriers to the recruitment and participation of minorities in cancer clinical trials as well possible strategies combating such barriers [22]. The involvement of clinical trial nurses in research is expected to improve the quality of conduct and outcomes in clinical trials [29]. However, existing literature provides inadequate information regarding barriers that limit minorities’ participation and access to cancer clinical trials. This paper aims to describe common barriers to the participation of ethnic and racial minorities in cancer clinical trials and discuss the facilitators and possible strategies that could improve the recruitment rate of racial/ ethnic minorities in future cancer clinical trials. In addition, it may raise the awareness of and provide directions to nurses in their efforts to recruit and/or facilitate the
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enrollment of racial and ethnic minorities into future cancer clinical trials and nursing cancer research.
Background and Significances Disparities in cancer burden among racial and ethnic minorities greatly reflect barriers to receiving health care services [2]. To achieve the goal of eliminating health disparities and promoting equality among all people, the National Institute of Health (NIH) identified that promoting the inclusion of minorities and underserved groups in clinical trials is one of its priorities [10, 43]. It is crucial that people from all racial and ethnic groups participate in cancer studies [31]. Studies with culturally appropriate interventions could lessen and help with overcoming these health disparities [26–28]. However, recruiting racial/ethnic minorities to research and clinical studies has commonly been a notable challenge reported by researchers [15, 20, 39, 40, 46]. Well-designed clinical trials with representative samples play a major role in generating and establishing evidencebased practices [18, 35]. However, even with the government’s efforts, the underrepresentation of racial/ethnic minorities in the samples of cancer clinical trials has been a notable concern [7, 13, 31, 40]. The participation rate of minorities in cancer clinical trials was reported as low as 3–20 % [9]. Insufficient numbers of minority participants in these trials could diminish the generalizability of cancer treatment effectiveness. It is crucial to include diverse people from all groups as participants in cancer clinical trials in order to find detection and treatment options that are effective for people in all racial and ethnic groups [26]. Identifying the factors that create barriers for racial and ethnic minorities’ participation in clinical trials can enhance our capabilities to reduce health disparities [26–28]. Nurses play an essential role in the effective conduct of cancer clinical trials [22, 29]. The Oncology Nursing Society (ONS) emphasizes that oncology clinical trial nurses should be able to utilize strategies to overcome barriers to the recruitment of a diverse patient population into cancer clinical trials [22, 29]. However, barriers and facilitators to recruiting racial and ethnic minorities in cancer clinical trials are rarely reported by nursing researchers. This limited information provided from the nurses’ perspective presents a great gap in our nursing knowledge. This knowledge gap could weaken nurses’ capabilities to implement evidence-based practices in caring for cancer patients and providing equal quality care to racial and ethnic minorities. Therefore, understanding and identifying the common barriers to and effective strategies for recruitment of racial and ethnical minorities may enable clinical nurses and researchers to be more competent in recruiting minority cancer patients to future oncology studies.
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Methods and Selection of Articles The investigation was conducted by reviewing relevant articles published in health care research databases from 2000 to 2013. A preliminary search was carried out via CINAHL, PubMed, PsycINFO, Medline, and Google Scholar. Several keywords such as ‘‘cancer’’, ‘‘oncology’’, and ‘‘clinical trial’’ were used for the initial search. Searches were also limited to articles written in English, research articles, and peer reviewed. With all the specificities and limitations, 58 articles were resulted from the search. Results of the initial search were also screened manually according to several selection criteria in order to find appropriate articles for detailed review. The selection criteria are as follows: that the contents of the articles provide information regarding cancer clinical trial participation, factors related to cancer clinical trial participation, and barriers of cancer clinical trial participation. A total of 28 articles selected were reviewed and discussed by the authors to identify the reported common barriers of recruitment to cancer clinical trials as well as the challenges to enrolling racial and ethnic minorities. Among these 28 selected articles, only eight articles were published by nurses or included nurses as authors. The majority of the articles providing information about racial and ethnic minorities’ participation was published by physicians.
Barriers to the Enrollments of Cancer Clinical Trials The major barriers to clinical trial participation revealed in most of the reviewed articles could be categorized into three main themes: physician related, patient related and system related. While several articles reporting and discussing these barriers to ethnic minorities’ participations in cancer clinical trials were published and written by professionals from different disciplines (such as medicine, public health, and/or social work), studies that offer perspectives and insights from nurses were extremely limited. Health Care Providers/Physician Related Barriers Health care providers as ‘‘gatekeepers’’ have direct influence on the participation rate of their patients. The barriers created by the healthcare providers/physicians include: lack of awareness, attitude, personal bias, communication method, and their perceived cost burden on their patients [8, 13, 31]. Lack of awareness about the availability of protocols or the existence of clinical trials was the main inhibitor for healthcare providers (and/or physicians) to discuss trial participation with patients and was a significant factor to the low accrual of participation among minority populations [13, 42].
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Attitudes of healthcare providers (and/or physicians) toward recruiting patients to clinical trials were also found to be a contributing factor to the enrollment of cancer patients [8, 21, 42]. Some physicians did not see the significance or value of clinical trials for their patients [21]. Healthcare providers’ (and/or physicians’) attitudes that could lead to low enrollment were related to their perception of patients’ specific situations and/or preferences, patients’ incompatibility with the trial, their ability to adhere to the trial’s requirements, and the expected quality of the outcomes [8]. Healthcare providers’ (and/or physicians’) lack of communication also poses a significant barrier to the recruitment of racial and ethnic minorities to clinical trials. Communication problems evolve from the physicians’ interpretation and presentation of clinical trials and their consideration of their patients’ capacity to comprehend the technicalities of the proposed clinical trials. This communication problem also stems from insensitivity to the patient’s culture, educational level and health literacy [13].
documented that the complexities of consent forms and procedures prevented racial/ethnic minority populations from participating [14, 21, 42]. It is very difficult for some ethnic populations (e.g. Asian Americans) to understand the need and the purpose of consent procedures [20]. The consent procedure could be perceived as something ‘‘suspicious’’, and signing the informed consent could be viewed as ‘‘taking risks and giving away their rights’’ by some ethnic populations [20]. The active consent increases the challenges of the recruiting process of ethnic minority populations [20]. Cultural values, beliefs and myths regarding health practices, specific diseases and treatments may also influence ethnic minority cancer patients’ willingness to participate in cancer clinical trials [42]. Many ethnic minorities believe in herbal medicine or other complementary/alternative health practices, and these cultural health beliefs and practices may be in conflict with enrollment in cancer clinical trials and result in reducing willingness to participate [14, 46].
Patient Related Barriers
System Related Barriers
Patient age, gender, ethnicity, socioeconomic status, and perceptions greatly impact the participation rate of a clinical trial [1, 7, 16, 25, 30, 45]. Some ethnic populations such as African Americans, Hispanics, Asian Americans and Native Americans are underrepresented in cancer clinical trials [7, 25]. Many of the patient-related barriers to participation occur within a socio-cultural context that affects an individual’s beliefs, attitudes, and health related decision-making [46]. Also of note were linguistic and literacy barriers’ influence on the opportunities of minority patients’ participation [7, 30, 46]. Lack of written trial information in the targeted population’s native language was also shown to impair the patients’ understandings and knowledge about the trials and negatively impacted their willingness to participate [7]. Patients’ perceptions about cancer clinical trials are also barriers contributing to ethnic minorities’ low rate of participation. It was found that possible adverse effects or risks perceived by the patients are common causes for their refusal to participate in cancer clinical trials [42, 45]. Another notable factor related to patients’ participation in cancer clinical trials is the relationship between the patient and their physician. Fear and mistrust were found as a common barrier to ethnic minorities’ participation in clinical trials [14, 32, 34, 46]. Common barriers to the recruitment of minorities in research and clinical studies were found to be mostly related to cultural differences such as language barriers, and cultural belief between researchers/healthcare providers and the minority subjects [20, 39, 46]. Literature also
Some system-related factors are also found as barriers for patients’ participation in cancer clinical trials. These factors include the design of clinical trials, the inclusion and exclusion criteria of the trials, lack of access to health care services, and concerns related to health care insurance [1, 8, 34, 40]. The strict eligibility criteria of the protocols make trials inaccessible to many patients [1, 19]. Most cancer clinical trials are only available at academic and cancer centers, and the accessibility of the cancer clinical trials is very limited for most of the ethnic minority cancer patients who live in and receive the treatment in their ethnic community, such as Chinatown [11, 21]. It was found that many minority physicians would like to help in the trials but did not have the infrastructures or support to do it [21]. Studies also found that insurance coverage can hinder patients’ access to clinical trials [16]. Most patients who declined participation considered cost as the most important component in their decisions [45]. Patients feared their enrollment would be denied due to inadequate coverage [19]. Socioeconomic disadvantages were directly related to ethnic minorities’ lack of participation in clinical trials [46].
Discussions and Implications Some strategies and facilitators were recommended to increase ethnic/racial minority patients’ participation in cancer clinical trials. These facilitators to the recruitment of ethnic minorities in cancer clinical trials require the
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involvements of ethnic minority health care professionals, families, and communities, with considerations of culturally sensitive approaches.
Facilitators to the Recruitment of Minorities in Cancer Clinical Trials Community based programs and networking have been suggested as effective strategies for improving ethnic minorities’ participations in research and clinical trials [17, 20, 24, 31]. Developing relationships with key community leaders, spokespersons and networks (such as political leaders, religious organizations, respected community elders, and civic community members) could help with gaining insight into recruitment barriers as well as being more effective in overcoming these barriers in that community, and raising community awareness regarding the importance of cancer clinical trials and their benefits to the minority patients in the community [31]. Health care provider/physician related barriers require changes in both the physicians’ and clinical administrators’ attitudes and perceptions of trials and their participants. In addition, there is a need to assess the physicians’ knowledge, beliefs and bias about the clinical trials in future studies [13, 19]. Research on outcomes of communication between cancer patients and health care professionals is important [4, 6]. Patient knowledge regarding the opportunity to join a cancer clinical trial is associated with increased participation rates and is essential to better health outcomes [4, 12]. It is recommended that improvements in communication skills between health care providers and their ethnic minority cancer patients may be needed [13, 31]. Patients’ racial and ethnic backgrounds, education, and their abilities to comprehend should be assessed and considered before discussing possible clinical trials in order to provide and explain the information about cancer clinical trials in a manner that is culturally sensitive and appropriate to the patient’s literacy level [13]. Effective and appropriate communication between health care providers and the potential participants may increase the patients’ willingness and ability to adhere to the trial’s requirements. Having diversified staffs who are bilingual and bicultural involved in the recruitment of ethnic minority participants is related to higher enrollment rates [24, 31, 41]. Ethnic minority health care professionals may be able to better discuss with their minority patients about concerns related to participation, explain the information about trials, build trust and rapport and select the appropriate clinical trials for their minority patients [31]. Involving minority patients’ family members in the discussion and decision-making process is also recommended for the recruitment and enrollment of minority patients [30,
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31]. Many patients discuss with family members before making medical and treatment decisions, and family involvement plays a significant role in ethnic minority cancer patients’ decision making regarding treatment [21, 31, 42]. In some ethnic minority cultures, family members are always involved in the health-decision making of the patients. For example, in families with Chinese cultural background, the senior male member is highly respected and has the power to make decisions for family members [21, 42]. Identifying the most effective mass media for use in study promotion and recruitment has been suggested to improve the recruitment of ethnic minorities in cancer clinical trials [14]. It is common for ethnic minorities to get their health care information from local mass communication media (e.g. Chinese television and Chinese language newspapers) and from their doctors, health clinics, hospitals, and by word of mouth [21]. Providing health education programs delivered by these local ethnic minorities’ mass communication media and using more appropriate language and literacy level to increase the awareness of availability and knowledge about cancer clinical trials could be a useful strategy to increase ethnic minorities’ participations in cancer clinical trials [21]. The Implications for Nurses to Recruit Racial/ Ethnic Minorities in Cancer Clinical Trails High-quality clinical research is necessary for the advancement of cancer care, control, and prevention; it is accomplished most effectively with the engagement of clinical trial nurses [11, 22]. Increasing ethnic minority populations and the issue of disparate cancer outcomes for ethnic minorities in the United States compel nurses to understand and to address the problem of under-representation of ethnically diverse populations in cancer research [17]. Nurses play a critical role in effectively coordinating cancer clinical trials, recruiting patients and in ensuring that the trial protocol and practice guidelines are well followed by every team member involved in the trial [11, 23, 29]. Including ethnic minority nurses and clinical trial coordinators in research teams not only could diminish the barriers related to language, mistrust of the health care providers, and minority patients’ fears and concerns about the trials, but also could improve the communication between cancer patients and health professionals and promote the ethnic minority patients’ and families’ understanding about the availability and accessibility of clinical trials [14, 29]. It is also necessary to increase the ethnic minority cancer patients’ understanding about the purpose of consent procedures to overcome the barriers of recruiting ethnic minority cancer patients. It is essential to emphasize that the intention of the informed consent is to protect the participants rather than to ask them to give up their legal
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rights or to take risks for something unpredictable and suspicious. The key members in certain minorities’ communities and translators with the cultural backgrounds of certain minorities may be trained about the clinical trials and the recruiting processes to assist in the processes of active informed consent. It has been found that nurses are eager to advocate cancer clinical trials but need more education to be competent in their roles [44]. Therefore, it is important to provide educational programs for nurses to enhance their knowledge and positive attitudes about cancer clinical trials as well as to prepare nurses to be culturally competent in their roles as team members in cancer research and clinical trials. The Oncology Nurse Society (ONS) Steering Council has developed the guidelines of Clinical Trial Nurse competencies and a Clinical Trials 101 on-line course to help clinical nurses to be competent with their roles in cancer clinical trials [29]. These competencies are expected to be used in research, academia, and professional organizations as a starting point for standardizing the role of clinical trial nurses, developing curricula, and designing certification programs [22]. It is also important for nurses to develop and understand the cultural dimension of care for the patients from different cultural backgrounds [36, 37]. Nursing educational programs that include the components of cultural competencies could help nurses to be aware of how patients interpret their health issues or illnesses and be capable to provide culturally competent care [37]. Such cultural competencies are important for nurses to efficiently approach minority cancer patients and increase enrollment rate to achieve our goal of reducing health disparities and providing quality care to all people.
are fluent in other languages is suggested for future investigations.
Limitations of this Study
References
The authors acknowledge that there may be limitations of this investigation. Latinos and Hispanics are the largest ethnic and racial minority groups accounted for 16.9% of the US population [43]. It is possible that some articles about recruiting Latinos and Hispanics to cancer clinical trials are published in Spanish. Due to the limitations of the authors’ capabilities in understanding Spanish, this study only investigated literature published in English. Consequently, it is possible that some valuable literature written in other languages might have been missed. Additional understanding of barriers and facilitators to recruit minorities with various ethnic and racial backgrounds is needed in order to be more effective in recruiting them to cancer clinical trials. Therefore, including researchers who
Conclusion Cancer clinical trials provide opportunities to advance scientists’ knowledge as well as provide up-to-date care to people enrolled in the trials. However, there are problems with the current clinical trials that need to be dealt with. These problems lie in the factors that impede the participation of cancer patients in general and even more so among racial/ethnic minorities. Barriers to participation raise two important aspects: low enrollment rate and lack of diversity in the studied samples. The lack of sample diversity can greatly compromise the outcomes of the trials since cancer varies greatly among gender, races, and cultures. More clinical research to validate the efficacy of proposed interventions is needed to provide evidence for quality and safe practices. Nursing professionals play significant roles in providing care to cancer patients and have the responsibility to advance cancer care and get involved in cancer clinical trials and research. Being aware of barriers that impede the diversity of clinical trials’ samples is an essential step to increase nurses’ competencies in caring for cancer patients and to enhance nurses’ capabilities in improving outcomes of cancer treatment and research. Information provided in this review can aid to increase nurses’ knowledge and competency regarding cancer clinical trials and may help nursing researchers gain insight into designing clinical cancer studies with samples that better represent the increasingly diverse US population.
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ORIGINAL PAPER
A Review of Barriers to Minorities’ Participation in Cancer Clinical Trials: Implications for Future Cancer Research Ali Salman1 • Claire Nguyen2 • Yi-Hui Lee3 • Tawna Cooksey-James4
Ó Springer Science+Business Media New York 2015
Abstract To enhance nurses’ awareness and competencies in practice and research by reporting the common barriers to participation of minorities in cancer clinical trials and discussing facilitators and useful strategies for recruitment. Several databases were searched for articles published in peer reviewed journals. Some of the barriers to minorities’ participation in clinical trials were identified within the cultural social-context of cancer patients. The involvement of community networking was suggested as the most effective strategy for the recruitment of minorities in cancer clinical trials. Using culturally sensitive approaches to enhance ethnic minorities’ participation is important for advancing cancer care and eliminating health disparities. Awareness of barriers and potential facilitators to the enrollment of ethnic minority cancer patients may contribute to enhancing nurses’ competencies of recruiting ethnic minorities in nursing research, playing efficient roles in cancer clinical trials team, and providing culturally competent quality care. Keywords Clinical trials Cancer Ethnic minority Barriers Recruitment
& Yi-Hui Lee [email protected] 1
Faculty of Health Studies, Brandon University, Brandon, MB R7A 6A9, Canada
2
Inova Mount Vernon Hospital, Alexandria, VA 22306, USA
3
College of Nursing and Health, Wright State UniversityMiami Valley, 3640 Colonel Glenn Hwy., Dayton, OH 45435-0001, USA
4
School of Nursing, Ohio University, Athens, OH 45701, USA
Introduction Cancer is a major health concern and the second leading cause of death in the United States, second to heart disease [5]. In 2012, a total of 577,190 cancer deaths were recorded in the United States, and about 580,350 Americans were expected to die of cancer in 2013 [3]. It has been well documented that cancer incidence and death rates vary considerably among different racial and ethnic groups [3, 26, 38]. Many racial and ethnic groups in the United States and around the world are affected disproportionately by certain types of cancers [26]. As a result, it has become a national and global goal to reduce health disparities and promote equality among all people [10]. The importance of culturally competent care has been stressed in nursing research and practice. It has been suggested that including cultural competence in research has a greater potential to inform nursing practice and help to shape health policy related to racial and ethnic minority populations [33]. Nurses, especially oncology nurses, should be aware of the barriers to the recruitment and participation of minorities in cancer clinical trials as well possible strategies combating such barriers [22]. The involvement of clinical trial nurses in research is expected to improve the quality of conduct and outcomes in clinical trials [29]. However, existing literature provides inadequate information regarding barriers that limit minorities’ participation and access to cancer clinical trials. This paper aims to describe common barriers to the participation of ethnic and racial minorities in cancer clinical trials and discuss the facilitators and possible strategies that could improve the recruitment rate of racial/ ethnic minorities in future cancer clinical trials. In addition, it may raise the awareness of and provide directions to nurses in their efforts to recruit and/or facilitate the
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enrollment of racial and ethnic minorities into future cancer clinical trials and nursing cancer research.
Background and Significances Disparities in cancer burden among racial and ethnic minorities greatly reflect barriers to receiving health care services [2]. To achieve the goal of eliminating health disparities and promoting equality among all people, the National Institute of Health (NIH) identified that promoting the inclusion of minorities and underserved groups in clinical trials is one of its priorities [10, 43]. It is crucial that people from all racial and ethnic groups participate in cancer studies [31]. Studies with culturally appropriate interventions could lessen and help with overcoming these health disparities [26–28]. However, recruiting racial/ethnic minorities to research and clinical studies has commonly been a notable challenge reported by researchers [15, 20, 39, 40, 46]. Well-designed clinical trials with representative samples play a major role in generating and establishing evidencebased practices [18, 35]. However, even with the government’s efforts, the underrepresentation of racial/ethnic minorities in the samples of cancer clinical trials has been a notable concern [7, 13, 31, 40]. The participation rate of minorities in cancer clinical trials was reported as low as 3–20 % [9]. Insufficient numbers of minority participants in these trials could diminish the generalizability of cancer treatment effectiveness. It is crucial to include diverse people from all groups as participants in cancer clinical trials in order to find detection and treatment options that are effective for people in all racial and ethnic groups [26]. Identifying the factors that create barriers for racial and ethnic minorities’ participation in clinical trials can enhance our capabilities to reduce health disparities [26–28]. Nurses play an essential role in the effective conduct of cancer clinical trials [22, 29]. The Oncology Nursing Society (ONS) emphasizes that oncology clinical trial nurses should be able to utilize strategies to overcome barriers to the recruitment of a diverse patient population into cancer clinical trials [22, 29]. However, barriers and facilitators to recruiting racial and ethnic minorities in cancer clinical trials are rarely reported by nursing researchers. This limited information provided from the nurses’ perspective presents a great gap in our nursing knowledge. This knowledge gap could weaken nurses’ capabilities to implement evidence-based practices in caring for cancer patients and providing equal quality care to racial and ethnic minorities. Therefore, understanding and identifying the common barriers to and effective strategies for recruitment of racial and ethnical minorities may enable clinical nurses and researchers to be more competent in recruiting minority cancer patients to future oncology studies.
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Methods and Selection of Articles The investigation was conducted by reviewing relevant articles published in health care research databases from 2000 to 2013. A preliminary search was carried out via CINAHL, PubMed, PsycINFO, Medline, and Google Scholar. Several keywords such as ‘‘cancer’’, ‘‘oncology’’, and ‘‘clinical trial’’ were used for the initial search. Searches were also limited to articles written in English, research articles, and peer reviewed. With all the specificities and limitations, 58 articles were resulted from the search. Results of the initial search were also screened manually according to several selection criteria in order to find appropriate articles for detailed review. The selection criteria are as follows: that the contents of the articles provide information regarding cancer clinical trial participation, factors related to cancer clinical trial participation, and barriers of cancer clinical trial participation. A total of 28 articles selected were reviewed and discussed by the authors to identify the reported common barriers of recruitment to cancer clinical trials as well as the challenges to enrolling racial and ethnic minorities. Among these 28 selected articles, only eight articles were published by nurses or included nurses as authors. The majority of the articles providing information about racial and ethnic minorities’ participation was published by physicians.
Barriers to the Enrollments of Cancer Clinical Trials The major barriers to clinical trial participation revealed in most of the reviewed articles could be categorized into three main themes: physician related, patient related and system related. While several articles reporting and discussing these barriers to ethnic minorities’ participations in cancer clinical trials were published and written by professionals from different disciplines (such as medicine, public health, and/or social work), studies that offer perspectives and insights from nurses were extremely limited. Health Care Providers/Physician Related Barriers Health care providers as ‘‘gatekeepers’’ have direct influence on the participation rate of their patients. The barriers created by the healthcare providers/physicians include: lack of awareness, attitude, personal bias, communication method, and their perceived cost burden on their patients [8, 13, 31]. Lack of awareness about the availability of protocols or the existence of clinical trials was the main inhibitor for healthcare providers (and/or physicians) to discuss trial participation with patients and was a significant factor to the low accrual of participation among minority populations [13, 42].
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Attitudes of healthcare providers (and/or physicians) toward recruiting patients to clinical trials were also found to be a contributing factor to the enrollment of cancer patients [8, 21, 42]. Some physicians did not see the significance or value of clinical trials for their patients [21]. Healthcare providers’ (and/or physicians’) attitudes that could lead to low enrollment were related to their perception of patients’ specific situations and/or preferences, patients’ incompatibility with the trial, their ability to adhere to the trial’s requirements, and the expected quality of the outcomes [8]. Healthcare providers’ (and/or physicians’) lack of communication also poses a significant barrier to the recruitment of racial and ethnic minorities to clinical trials. Communication problems evolve from the physicians’ interpretation and presentation of clinical trials and their consideration of their patients’ capacity to comprehend the technicalities of the proposed clinical trials. This communication problem also stems from insensitivity to the patient’s culture, educational level and health literacy [13].
documented that the complexities of consent forms and procedures prevented racial/ethnic minority populations from participating [14, 21, 42]. It is very difficult for some ethnic populations (e.g. Asian Americans) to understand the need and the purpose of consent procedures [20]. The consent procedure could be perceived as something ‘‘suspicious’’, and signing the informed consent could be viewed as ‘‘taking risks and giving away their rights’’ by some ethnic populations [20]. The active consent increases the challenges of the recruiting process of ethnic minority populations [20]. Cultural values, beliefs and myths regarding health practices, specific diseases and treatments may also influence ethnic minority cancer patients’ willingness to participate in cancer clinical trials [42]. Many ethnic minorities believe in herbal medicine or other complementary/alternative health practices, and these cultural health beliefs and practices may be in conflict with enrollment in cancer clinical trials and result in reducing willingness to participate [14, 46].
Patient Related Barriers
System Related Barriers
Patient age, gender, ethnicity, socioeconomic status, and perceptions greatly impact the participation rate of a clinical trial [1, 7, 16, 25, 30, 45]. Some ethnic populations such as African Americans, Hispanics, Asian Americans and Native Americans are underrepresented in cancer clinical trials [7, 25]. Many of the patient-related barriers to participation occur within a socio-cultural context that affects an individual’s beliefs, attitudes, and health related decision-making [46]. Also of note were linguistic and literacy barriers’ influence on the opportunities of minority patients’ participation [7, 30, 46]. Lack of written trial information in the targeted population’s native language was also shown to impair the patients’ understandings and knowledge about the trials and negatively impacted their willingness to participate [7]. Patients’ perceptions about cancer clinical trials are also barriers contributing to ethnic minorities’ low rate of participation. It was found that possible adverse effects or risks perceived by the patients are common causes for their refusal to participate in cancer clinical trials [42, 45]. Another notable factor related to patients’ participation in cancer clinical trials is the relationship between the patient and their physician. Fear and mistrust were found as a common barrier to ethnic minorities’ participation in clinical trials [14, 32, 34, 46]. Common barriers to the recruitment of minorities in research and clinical studies were found to be mostly related to cultural differences such as language barriers, and cultural belief between researchers/healthcare providers and the minority subjects [20, 39, 46]. Literature also
Some system-related factors are also found as barriers for patients’ participation in cancer clinical trials. These factors include the design of clinical trials, the inclusion and exclusion criteria of the trials, lack of access to health care services, and concerns related to health care insurance [1, 8, 34, 40]. The strict eligibility criteria of the protocols make trials inaccessible to many patients [1, 19]. Most cancer clinical trials are only available at academic and cancer centers, and the accessibility of the cancer clinical trials is very limited for most of the ethnic minority cancer patients who live in and receive the treatment in their ethnic community, such as Chinatown [11, 21]. It was found that many minority physicians would like to help in the trials but did not have the infrastructures or support to do it [21]. Studies also found that insurance coverage can hinder patients’ access to clinical trials [16]. Most patients who declined participation considered cost as the most important component in their decisions [45]. Patients feared their enrollment would be denied due to inadequate coverage [19]. Socioeconomic disadvantages were directly related to ethnic minorities’ lack of participation in clinical trials [46].
Discussions and Implications Some strategies and facilitators were recommended to increase ethnic/racial minority patients’ participation in cancer clinical trials. These facilitators to the recruitment of ethnic minorities in cancer clinical trials require the
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involvements of ethnic minority health care professionals, families, and communities, with considerations of culturally sensitive approaches.
Facilitators to the Recruitment of Minorities in Cancer Clinical Trials Community based programs and networking have been suggested as effective strategies for improving ethnic minorities’ participations in research and clinical trials [17, 20, 24, 31]. Developing relationships with key community leaders, spokespersons and networks (such as political leaders, religious organizations, respected community elders, and civic community members) could help with gaining insight into recruitment barriers as well as being more effective in overcoming these barriers in that community, and raising community awareness regarding the importance of cancer clinical trials and their benefits to the minority patients in the community [31]. Health care provider/physician related barriers require changes in both the physicians’ and clinical administrators’ attitudes and perceptions of trials and their participants. In addition, there is a need to assess the physicians’ knowledge, beliefs and bias about the clinical trials in future studies [13, 19]. Research on outcomes of communication between cancer patients and health care professionals is important [4, 6]. Patient knowledge regarding the opportunity to join a cancer clinical trial is associated with increased participation rates and is essential to better health outcomes [4, 12]. It is recommended that improvements in communication skills between health care providers and their ethnic minority cancer patients may be needed [13, 31]. Patients’ racial and ethnic backgrounds, education, and their abilities to comprehend should be assessed and considered before discussing possible clinical trials in order to provide and explain the information about cancer clinical trials in a manner that is culturally sensitive and appropriate to the patient’s literacy level [13]. Effective and appropriate communication between health care providers and the potential participants may increase the patients’ willingness and ability to adhere to the trial’s requirements. Having diversified staffs who are bilingual and bicultural involved in the recruitment of ethnic minority participants is related to higher enrollment rates [24, 31, 41]. Ethnic minority health care professionals may be able to better discuss with their minority patients about concerns related to participation, explain the information about trials, build trust and rapport and select the appropriate clinical trials for their minority patients [31]. Involving minority patients’ family members in the discussion and decision-making process is also recommended for the recruitment and enrollment of minority patients [30,
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31]. Many patients discuss with family members before making medical and treatment decisions, and family involvement plays a significant role in ethnic minority cancer patients’ decision making regarding treatment [21, 31, 42]. In some ethnic minority cultures, family members are always involved in the health-decision making of the patients. For example, in families with Chinese cultural background, the senior male member is highly respected and has the power to make decisions for family members [21, 42]. Identifying the most effective mass media for use in study promotion and recruitment has been suggested to improve the recruitment of ethnic minorities in cancer clinical trials [14]. It is common for ethnic minorities to get their health care information from local mass communication media (e.g. Chinese television and Chinese language newspapers) and from their doctors, health clinics, hospitals, and by word of mouth [21]. Providing health education programs delivered by these local ethnic minorities’ mass communication media and using more appropriate language and literacy level to increase the awareness of availability and knowledge about cancer clinical trials could be a useful strategy to increase ethnic minorities’ participations in cancer clinical trials [21]. The Implications for Nurses to Recruit Racial/ Ethnic Minorities in Cancer Clinical Trails High-quality clinical research is necessary for the advancement of cancer care, control, and prevention; it is accomplished most effectively with the engagement of clinical trial nurses [11, 22]. Increasing ethnic minority populations and the issue of disparate cancer outcomes for ethnic minorities in the United States compel nurses to understand and to address the problem of under-representation of ethnically diverse populations in cancer research [17]. Nurses play a critical role in effectively coordinating cancer clinical trials, recruiting patients and in ensuring that the trial protocol and practice guidelines are well followed by every team member involved in the trial [11, 23, 29]. Including ethnic minority nurses and clinical trial coordinators in research teams not only could diminish the barriers related to language, mistrust of the health care providers, and minority patients’ fears and concerns about the trials, but also could improve the communication between cancer patients and health professionals and promote the ethnic minority patients’ and families’ understanding about the availability and accessibility of clinical trials [14, 29]. It is also necessary to increase the ethnic minority cancer patients’ understanding about the purpose of consent procedures to overcome the barriers of recruiting ethnic minority cancer patients. It is essential to emphasize that the intention of the informed consent is to protect the participants rather than to ask them to give up their legal
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rights or to take risks for something unpredictable and suspicious. The key members in certain minorities’ communities and translators with the cultural backgrounds of certain minorities may be trained about the clinical trials and the recruiting processes to assist in the processes of active informed consent. It has been found that nurses are eager to advocate cancer clinical trials but need more education to be competent in their roles [44]. Therefore, it is important to provide educational programs for nurses to enhance their knowledge and positive attitudes about cancer clinical trials as well as to prepare nurses to be culturally competent in their roles as team members in cancer research and clinical trials. The Oncology Nurse Society (ONS) Steering Council has developed the guidelines of Clinical Trial Nurse competencies and a Clinical Trials 101 on-line course to help clinical nurses to be competent with their roles in cancer clinical trials [29]. These competencies are expected to be used in research, academia, and professional organizations as a starting point for standardizing the role of clinical trial nurses, developing curricula, and designing certification programs [22]. It is also important for nurses to develop and understand the cultural dimension of care for the patients from different cultural backgrounds [36, 37]. Nursing educational programs that include the components of cultural competencies could help nurses to be aware of how patients interpret their health issues or illnesses and be capable to provide culturally competent care [37]. Such cultural competencies are important for nurses to efficiently approach minority cancer patients and increase enrollment rate to achieve our goal of reducing health disparities and providing quality care to all people.
are fluent in other languages is suggested for future investigations.
Limitations of this Study
References
The authors acknowledge that there may be limitations of this investigation. Latinos and Hispanics are the largest ethnic and racial minority groups accounted for 16.9% of the US population [43]. It is possible that some articles about recruiting Latinos and Hispanics to cancer clinical trials are published in Spanish. Due to the limitations of the authors’ capabilities in understanding Spanish, this study only investigated literature published in English. Consequently, it is possible that some valuable literature written in other languages might have been missed. Additional understanding of barriers and facilitators to recruit minorities with various ethnic and racial backgrounds is needed in order to be more effective in recruiting them to cancer clinical trials. Therefore, including researchers who
Conclusion Cancer clinical trials provide opportunities to advance scientists’ knowledge as well as provide up-to-date care to people enrolled in the trials. However, there are problems with the current clinical trials that need to be dealt with. These problems lie in the factors that impede the participation of cancer patients in general and even more so among racial/ethnic minorities. Barriers to participation raise two important aspects: low enrollment rate and lack of diversity in the studied samples. The lack of sample diversity can greatly compromise the outcomes of the trials since cancer varies greatly among gender, races, and cultures. More clinical research to validate the efficacy of proposed interventions is needed to provide evidence for quality and safe practices. Nursing professionals play significant roles in providing care to cancer patients and have the responsibility to advance cancer care and get involved in cancer clinical trials and research. Being aware of barriers that impede the diversity of clinical trials’ samples is an essential step to increase nurses’ competencies in caring for cancer patients and to enhance nurses’ capabilities in improving outcomes of cancer treatment and research. Information provided in this review can aid to increase nurses’ knowledge and competency regarding cancer clinical trials and may help nursing researchers gain insight into designing clinical cancer studies with samples that better represent the increasingly diverse US population.
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